Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Postoperative Pain
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Subjects will be randomized to 2 groups. One group will receive the Caudal block. The other group will receive the Pudendal block.Masking: Double (Participant, Outcomes Assessor)Masking Description: The study will be an observer-blinded RCT. The surgeon, regional pediatric anesthesiologist, and operating room staff (anesthesiologists and nurses) will not be blinded to the treatment group. However, the patient and family, recovery room nurses, and study coordinator who collects the data from families will be blindedPrimary Purpose: Treatment

Participation Requirements

Age
Younger than 62 years
Gender
Both males and females

Description

The study participation will begin on the day of surgery and end at the time of last surgical follow-up visit, approximately two weeks later. All procedure related, follow-up clinic visit and PACU data will be collected by the research team from the patient's EPIC record (demographic data, pain scor...

The study participation will begin on the day of surgery and end at the time of last surgical follow-up visit, approximately two weeks later. All procedure related, follow-up clinic visit and PACU data will be collected by the research team from the patient's EPIC record (demographic data, pain scores in the PACU, analgesic consumption, time to perform block, time to discharge, etc). Data pertaining to the recovery of patient at home will be collected via phone call or email to the caregiver of the child. Late complications will be identified by reviewing the follow-up surgical note. Questionnaire Administration The physical Pain journal/questionnaires The physical Pain journal/questionnaires will be handed out to the caregiver before discharge from the Post-Anesthesia Care Unit. The answers to the Pain Journal/Questionnaire will be retrieved in 3 potential ways (depending on the caregiver's preference or availability): By phone call at 24-48h By answering a REDCap questionnaire Bringing the physical forms to the surgeon's office at the 2 week visit The caregiver will fill out pain scores at home in the Pain Journal. The pain scores used (FLACC and PPPM) have been extensively validated. In addition, written instructions for using the pain scores to guide pain management interventions at home will be provided. Prior to discharge, caregivers will also be educated by a member of the research team on pain evaluation using the pain score and pain management algorithm. The caregiver will be asked to answer a short questionnaire (Postoperative Parent Survey) about their child pain in the first 24 hours after discharge from the hospital. The caregiver will receive a phone call from the research team 24-48 hours after discharge to retrieve the results of the Pain Journal and Postoperative Pain Survey. If the parent could not be contacted by phone after two attempts, an email containing a REDCap survey with the same questions from the Pain Journal and Pain Survey will be sent automatically after discharge to the caregiver, in the hope that the parent would be able to answer the questions at a more convenient time. The email will contain a REDCap survey with the same questions from the Pain Journal and Pain Survey.

Tracking Information

NCT #
NCT04840654
Collaborators
Not Provided
Investigators
Principal Investigator: Alina Lazar, MD University of Chicago